BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC QUANTUM APEX?

    MDR report key: 3232538 · Received July 18, 2013

    Report

    Report Number
    2134265-2013-04788
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE NC QUANTUM APEX CATHETER WAS RECEIVED INSIDE AN NC QUANTUM APEX SHELF BOX THAT MATCHED THE INFORMATION ON THE DEVICE. THERE WAS A STOPCOCK ATTACHED TO THE INFLATION PORT. THERE WAS BLOOD IN THE GUIDEWIRE LUMEN. THE BALLOON WAS DEFLATED, AS-RECEIVED. MAGNIFIED INSPECTION REVEALED NO DAMAGE. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER LEAKED FROM THE HYPOTUBE NEAR THE PROXIMAL END OF THE DEVICE. MAGNIFIED INSPECTION OF THE PROXIMAL END OF THE DEVICE REVEALED A HYPOTUBE SEPARATION IN THE PORTION OF THE SHAFT WITHIN THE STRAIN RELIEF. THERE WAS A SUBTLE BEND IN THE HYPOTUBE NEAR THE DISTAL SIDE OF THE FRACTURE, WHICH MAY INDICATE THE DEVICE WAS KINKED AT THIS LOCATION PRIOR TO FRACTURING. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE 15MM X 2.25MM NC QUANTUM APEX¿ BALLOON CATHETER WAS ADVANCE TO THE TARGET LESION. ON THE FIRST INFLATION AT 8 ATMOSPHERES, BLOOD FLOWED INTO THE INDEFLATOR. THE DEVICE WAS REMOVED AND CHECKED OUTSIDE THE PATIENT. IT WAS NOTED THAT THE BALLOON HAD BEEN RUPTURED. THE PROCEDURE WAS COMPLETED WITH A 2.25MM NON BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE 15MM X 2.25MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCE TO THE TARGET LESION. ON THE FIRST INFLATION AT 8 ATMOSPHERES, BLOOD FLOWED INTO THE INDEFLATOR. THE DEVICE WAS REMOVED AND CHECKED OUTSIDE THE PATIENT. IT WAS NOTED THAT THE BALLOON HAD BEEN RUPTURED. THE PROCEDURE WAS COMPLETED WITH A 2.25MM NON BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336121 NC QUANTUM APEX? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493912415220 15985026

    Patients

    Seq Age Sex Outcome Treatment
    1